It is well known in the art that extended release dosage forms are used to control the release of pharmaceutically active ingredients. These devices operate successfully for their intended use. However, these devices are often limited in their use to deliver pharmaceutical active ingredients in a pulsatile manner. These devices are also limited in their ability to mimic precisely the desirable in-vivo characteristics that multiple dosing per day regimen presents i.e., the ability to “switch on and switch off”, or provide pulsed or multiple peaks, troughs and plateau of drug concentration at predetermined time or time interval while still maintaining control on the rate and extent of drug input.
It will be appreciated by those versed in the art, that if a device can be provided that allows the delivery of pharmaceutically active ingredients their bases, salts, metabolites, pro-drugs, racemates, enantiomers, optical isomers, related substances or a mixture thereof in such a way that the shape, number, magnitude, position and timing of the plasma concentration peaks (maxima), troughs (minima) and plateaus and their inter relations can be controlled precisely such a device would have a positive value and represent an advancement in the science of controlled delivery technology. The present invention is directed to these, as well as other, significant outcome.